Protocol: Multicenter, validity and reliability study of home visual acuity testing
Status: Recruiting
Start Date: 03/30/2022
End Date:  
Clinical Trial ID: N/A
Public Dataset:  

 



X06 - Home Visual Acuity Testing

 

Protocol

Primary Objective:

    • The primary objective of the study is to compare home versus office based visual acuity methods. We will:
    1. Evaluate the proportion of eyes that have 1, 2, and 3 logMAR lines difference in VA between the two methods. 
    2. Construct limits of agreement between the two methods, 
    3. Construct a confidence interval for the mean difference between the two methods, 
    4. Compare repeatability coefficients between the two methods,
    5. Compare interclass correlations between the two methods
            Secondary Objective:
            • The secondary objectives include comparison of the same-day, different-day, short-term, and long-term repeatability of the phone-based method, evaluation of the agreement between in-office testing of the two methods, and whether the change in VA over time measured with the phone-based method agrees with the change measured using the office-based method. When testing VA in the office, the ATS-HOTV method will be used to measure VA in participants 3 to <7 years of age, and the e-ETDRS method will be used to measure VA in participants 7 to 17.5 years of age.



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